Melatonin 3 mg Sublingual Tablets

“Our meta-analysis demonstrated melatonin had a significant benefit in reducing sleep latency.”

“Melatonin was associated with a significant and moderate reduction in PSQI global scores, indicating improved sleep quality (Table 2).”

“Mean PSQI score post treatment was lower in the melatonin group compared to placebo (P = 0.037).”

“After treatment, the study group showed significantly decreased scores in HAMD, HAMA, and PSQI scales in contrast to the other.”

“Melatonin increased total sleep time as measured with sleep diaries (P=0.04), the primary outcome, but the confidence interval excluded the 60 minute value determined to be the minimum clinically relevant.”

“Melatonin reduced sleep onset latency when measured by both sleep diaries (P<0.001) and actigraphy (P<0.001).”

“SR melatonin reduced mean sleep latency by 11 min (p=0.02,) and mean WASO by 22 min (p=0.04,) as compared to placebo (Table 3).”

“The pooled SMD in healthy subjects showed that exogenous melatonin significantly decreased SOL compared to placebo.”

“The median in-hospital sleep duration was 6.0 hours (IQR: 5.0–6.2), with slightly longer duration in the melatonin group (6.0 (5.3–6.3) vs 5.8 (5.0–6.0), p=0.136), though this difference was not statistically significant.”

“In the high-dose group, overall there was significantly greater sleep efficiency and TST in the melatonin condition compared with the placebo condition (see Figure 2, upper panel).”

“In the 20 patients who completed the study, sleep onset latency was significantly reduced while subjects were taking melatonin as compared with both placebo and baseline.”

“Melatonin decreased sleep-onset latency by 23.27 minutes (95% CI: 4.83 -41.72 min).”

“Also, melatonin supplementation did not affect strength performance (0.19; 95% CI: -0.28 to 0.65).”

“Quantitative measures were appropriate with significant reductions in sleep onset latency (n = 6) in the melatonin condition relative to the placebo condition (p = 0.003), and bedtime resistance (n = 8) according to the CSHQ (p = 0.004).”

“Dose-response meta-analysis showed that melatonin gradually reduces sleep onset latency and increases total sleep time, peaking at 4 mg/day.”

“A significant and clinically relevant shortening of sleep latency to the same extent as most frequently used sleep medications was also found (-24.3 vs.-12.9 minutes; p = 0.028).”

“Lean mass increased (p = 0.025) while fat mass (p = 0.0013) and body mass index (p = 0.034) decreased in TMG compared with TPG.”

“Total time asleep increased with melatonin (19.8 +/- 61.9 minutes) as compared to placebo (-13.6 +/- 50.6 minutes; p = .01).”

“In comparison with placebo, 3 weeks of melatonin supplementation significantly increased total sleep time (+36 min; P = 0.046), increased sleep efficiency (+7.6%; P = 0.046), and decreased sleep onset latency to Stage 2 (-14 min; P = 0.001) as assessed by polysomnography.”

“A meta-analysis of nine studies (n=541) showed that melatonin significantly improved total sleep time compared with placebo (mean difference (MD)=48.26 min, 95% CI 36.78 to 59.73, I2=31%).”

“Melatonin treatment significantly reduced sleep onset latency by 4.0 min (95% CI 2.5, 5.4); increased sleep efficiency by 2.2% (95% CI 0.2, 4.2), and increased total sleep duration by 12.8 min (95% CI 2.9, 22.8).”

“By the end of the double-blind treatment, the PRM group had significantly shorter sleep onset latency (9 min; P = 0.02) compared with the placebo group and scored significantly better in the Critical Flicker Fusion Test (P = 0.008) without negatively affecting sleep structure and architecture.”

“There were no significant effects of melatonin on daytime sleepiness or sleep quality measured with ESS (p =.84) or PSQI (p =.11), respectively, but a small shift towards eveningness type was seen after melatonin treatment compared with placebo measured with MEQ (difference −2.3 [−3.7 to −0.9], p =.0036) (Table 4).”

“Lean mass increased (p = 0.025) while fat mass (p = 0.0013) and body mass index (p = 0.034) decreased in TMG compared with TPG.”

“Total fat content, total lean body mass, body weight, total bone mineral content, total bone mineral density (BMD), lumbar spine BMD, and total hip BMD were not significantly different after M compared with P (Table 2).”

“Total Sleep Time (SECONDARY, minutes) -- NCT01114360: Melatonin 399.8 +/-11.0 (n=36) vs Placebo 412.2 +/-11.1 (n=36); difference -12.4; p=0.52, no significant difference”

“Effects of melatonin treatment melatonin administration significantly increased global PSQI scores in the control group [control (+)] compared to untreated controls [control (−)] (p = 0.003).”

“There was a statistically significant increase in diary-reported total sleep time (TST), which was the most commonly reported outcome for melatonin compared with placebo [pooled mean difference 29.6 minutes, 95% confidence interval (CI) 6.9 to 52.4 minutes; p = 0.01]; however, statistical heterogeneity was extremely high (97%).”

“Total Sleep Time (SECONDARY, minutes) -- NCT01114373: Melatonin 415.8 +/-10.9 (n=36) vs Placebo 413.4 +/-10.6 (n=36); difference 2.4; p=0.39, no significant difference”

“Nine randomised controlled trials with 427 participants showed no evidence that melatonin had an effect on sleep onset latency in people who had sleep disorders accompanying sleep restriction (-1.0 (-2.3 to 0.3) min).”

“There was no difference in total sleep or WASO between melatonin and placebo.”